Astrazeneca Plc - AZN STOCK NEWS

ENHERTU (trastuzumab deruxtecan) has received CHMP recommendation for EU approval as a monotherapy for patients with unresectable or metastatic HR positive, HER2 low or ultralow breast cancer. The recommendation is based on the DESTINY-Breast06 phase 3 trial results, which demonstrated:

- 38% reduction in disease progression/death risk vs chemotherapy
- Median progression-free survival of 13.2 months vs 8.1 months with chemotherapy
- Objective response rate of 56.5% vs 32.2% with chemotherapy
- Similar benefits observed in HER2 ultralow population

The safety profile aligned with previous trials, with notable adverse events including neutropenia (20.7%), leukopenia (6.9%), and anemia (5.8%). Interstitial lung disease occurred in 11.3% of patients, mostly low-grade.

AstraZeneca (AZN) announced positive interim results from the SERENA-6 Phase III trial for camizestrant, their next-generation oral SERD treatment for HR-positive breast cancer. The trial demonstrated highly statistically significant and clinically meaningful improvement in progression-free survival when combining camizestrant with CDK4/6 inhibitors.

The study evaluated switching to camizestrant combination versus continuing standard aromatase inhibitor treatment in 1st-line treatment of HR-positive, HER2-negative advanced breast cancer patients with emergent ESR1 mutations. The trial enrolled 315 patients and used a novel ctDNA-guided approach to detect endocrine resistance early.

While secondary endpoints including overall survival were immature at interim analysis, the treatment showed promising trends in time to second disease progression. The safety profile was consistent with known data, with low discontinuation rates across both arms.

SOPHiA GENETICS (Nasdaq: SOPH) has announced significant adoption of its MSK-ACCESS® and MSK-IMPACT® cancer testing applications powered by SOPHiA DDM™. Thirty-seven prominent institutions globally have adopted these recently launched Liquid Biopsy and Solid Tumor applications, with thirty-four specifically choosing MSK-ACCESS® within ten months of its launch.

Notable adopters include Heidelberg University Hospital, Hospital del Mar, Jewish General Hospital, and the Jiménez Díaz Foundation. The decentralized deployment enables institutions to conduct world-renowned testing in-house, offering less-invasive options for patients with potentially lower costs and faster turnaround times.

This milestone follows SOPHiA GENETICS' 2023 partnership with Memorial Sloan Kettering Cancer Center and their October 2024 agreement with AstraZeneca to accelerate MSK-ACCESS® deployment globally. The company launched MSK-IMPACT® for Solid Tumor testing in November 2024.

AstraZeneca's IMFINZI (durvalumab) demonstrated significant improvements in a post-hoc exploratory analysis of the NIAGARA Phase III trial for muscle-invasive bladder cancer (MIBC). The perioperative regimen, combining IMFINZI with neoadjuvant chemotherapy, showed improved event-free survival (EFS) and overall survival (OS) versus chemotherapy alone.

Key findings include:

• 42% risk reduction in disease progression for patients achieving pathologic complete response (pCR)
• 33% reduction in risk of distant metastases
• 31% reduction in risk of death specifically due to bladder cancer
• 10% improvement in pCR rate versus comparator arm

The treatment was generally well-tolerated with no new safety signals. IMFINZI received Priority Review in the US in December 2024, with regulatory applications under review in EU, Japan, and other countries.

Alexion, AstraZeneca Rare Disease has launched an interactive e-book titled 'Revealing the Secrets of aHUS' to help children understand atypical Haemolytic Uraemic Syndrome (aHUS), a rare kidney disease affecting 0.4-0.5 people per million. The storybook, developed in collaboration with Kidney Care UK and Newcastle National Renal Complement Therapeutics Centre, targets children aged 6-10.

The interactive book transforms complex medical information into an engaging adventure where readers become the 'Guardian of Healthoria.' Children can personalize their character and complete various challenges while learning about kidneys, the immune system, and aHUS management. The resource is available across multiple platforms, including laptops, tablets, mobile phones, and print.

The initiative addresses a significant need, as 3.5 million people in the UK live with rare diseases, with 75% of these conditions affecting children. The book focuses on four key areas: the patient journey, kidney function, emotional support, and the daily impact of aHUS.

AstraZeneca (AZN) reported strong financial results for FY 2024, with Total Revenue increasing 21% to $54,073m and Core EPS growing 19% to $8.21. The growth was driven by a 19% increase in Product Sales, along with significant growth in Alliance Revenue and Collaboration Revenue.

Revenue growth was robust across all segments: Oncology (24%), CVRM (20%), R&I (25%), V&I (8%), and Rare Disease (16%). The company declared a second interim dividend of $2.10 per share, bringing the total annual dividend for FY 2024 to $3.10, a 7% increase.

For FY 2025, AstraZeneca projects high single-digit percentage growth in Total Revenue and low double-digit percentage growth in Core EPS. The company achieved multiple regulatory approvals across major markets and reported positive clinical trial results, supporting their Ambition 2030 goal of reaching $80 billion Total Revenue by decade's end.

Datopotamab deruxtecan (Dato-DXd) has received a positive CHMP recommendation for EU approval in treating adult patients with unresectable or metastatic HR positive, HER2 negative breast cancer who have previously received endocrine therapy and chemotherapy in advanced settings.

The recommendation is based on the TROPION-Breast01 phase 3 trial results, which showed that Dato-DXd reduced the risk of disease progression or death by 37% compared to standard chemotherapy. The median progression-free survival was 6.9 months for Dato-DXd versus 4.9 months for chemotherapy. The objective response rate was 36% for Dato-DXd compared to 23% for chemotherapy.

The drug demonstrated a favorable safety profile with 21% of patients experiencing Grade 3 or higher treatment-related adverse events compared to 45% in the chemotherapy arm. The drug is already approved in Japan and the U.S., with additional regulatory submissions under review in China and other regions.

AstraZeneca and Daiichi Sankyo have initiated the TROPION-Lung12 Phase 3 trial, dosing their first patient to evaluate DATROWAY® (datopotamab deruxtecan) plus rilvegostomig or rilvegostomig monotherapy versus standard of care. The trial targets patients with stage 1 adenocarcinoma non-small cell lung cancer (NSCLC) after complete surgical resection who are ctDNA-positive or have high-risk pathological features.

Currently, stage 1 NSCLC treatment involves tumor resection, but up to 40% of patients may experience disease recurrence. While observation typically follows resection, adjuvant chemotherapy and/or immunotherapy may be offered to high-risk stage 1b patients. The trial aims to explore DATROWAY's potential role in combination with immunotherapy as an adjuvant treatment to prevent disease recurrence.

ENHERTU has received FDA approval for treating adult patients with unresectable or metastatic hormone receptor-positive, HER2-low or HER2-ultralow breast cancer that has progressed after endocrine therapies. The approval was based on the DESTINY-Breast06 Phase III trial, which demonstrated ENHERTU's superiority over chemotherapy with a median progression-free survival of 13.2 months versus 8.1 months.

The trial showed a 36% reduction in disease progression or death risk compared to chemotherapy, with a confirmed objective response rate of 62.6% for ENHERTU versus 34.4% for chemotherapy. The safety profile remained consistent with previous trials, with no new concerns identified. This approval expands ENHERTU's availability to an earlier HR-positive treatment setting and broadens the eligible patient population to include those with HER2-ultralow disease.